Mapping the Human Immunodeficiency Virus Chronobiome, (HIV)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time-of-day fluctuations in core clock gene expression
研究概览
简要总结
Individuals infected with HIV have a high risk of developing metabolic comorbidities not traditionally associated with the immune dysregulation and deficiency associated with HIV infection and AIDS. Many of these comorbidities in HIV uninfected individuals have been linked to a disordered circadian clock function. The study investigators will further evaluate the circadian clock in HIV infection as a mechanism underlying the metabolic dysregulation in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort 1: Diagnosis of HIV infection with CD4+ counts <500 cells/mm3 while untreated;
- •Cohort 2: Diagnosis of HIV infection with CD4+ counts <300 cells/mm3 on ARV;
- •Cohort 3: Volunteers must be in good health as based on medical history, physical examination, vital signs, and laboratory tests as deemed by PI;
- •Volunteers are capable of giving informed consent;
- •25-50 years of age;
- •Own a smartphone which installs the remote sensing applications;
- •Non-smoking;
- •Male subjects only if feasible during recruitment; and
- •In case female volunteers are invited to enroll: non-pregnant, female subjects must consent to a urine pregnancy test.
- •Females of child bearing potential will be asked to use a medically accepted method of birth control (such as oral contraceptives, intra-uterine device (IUD), or condom with spermicide) while you participate in the study.
- •The use of contraception will NOT be required for male participants.
排除标准
- •Recent travel across more than two (2) time zones (within the past month);
- •Planned travel across more than two (2) time zones during the planned study activities;
- •Volunteers with irregular work hours, e.g. night shifts or becoming a parent;
- •Use of illicit drugs;
- •High dose vitamins (Vitamin A, Vitamin C, Vitamin E, Beta Carotene, Folic Acid and Selenium), alcohol and any over-the counter NSAID in the (2) two weeks before the start of the 48 hour deep phenotyping period (Females who are taking birth control pills can continue so for the duration of this study).;
- •History of abdominal surgery;
- •Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening;
- •Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
- •Women who are breastfeeding.
研究组 & 干预措施
Cohort 3
Matched healthy volunteers
干预措施: Observational (Other)
Cohort 1
Patients infected with HIV off antiretroviral therapy
干预措施: Observational (Other)
Cohort 2
Patients infected with HIV experiencing virologic control, but with blunted immunologic recovery
干预措施: Observational (Other)
结局指标
主要结局
Time-of-day fluctuations in core clock gene expression
时间窗: 48 hours
Relative expression normalized to housekeeping genes (GAPDH, ACTB) plotted by time of day (morning, afternoon, evening, night with target times of 08:00, 14:00, 20:00, 02:00 +/- 1 hour)
次要结局
- Variance explained [R^2 values](up to 4 months)
- Variance explained [R^2 values](48 hours)
研究者
Carsten Skarke, MD
Research Assistant Professor
University of Pennsylvania